Lewis-Smith Helena, Jones Abigail, White Paul, Byford Sarah, Fairbrother Patricia, Potter Shelley, Harcourt Diana
University of the West of England, Bristol, UK
University of the West of England, Bristol, UK.
BMJ Open. 2025 Jan 22;15(1):e097817. doi: 10.1136/bmjopen-2024-097817.
Breast cancer is the most common cancer among women worldwide. While increasing numbers of women are living beyond breast cancer, treatment-related body image concerns are common and associated with adverse consequences. Nonetheless, rigorously evaluated and effective body image interventions are lacking among this group. ) has indicated promise in relation to inperson delivery. However, online delivery may increase accessibility and facilitate sustainability of the intervention. Therefore, we aim to establish the feasibility of conducting a fully powered randomised controlled trial to evaluate online delivery of .
120 women who have received treatment for breast cancer and are experiencing body image concerns will be randomised equally to either the or standard care control group. All participants in both conditions will receive a body image booklet for people who have had cancer. participants will also take part in a weekly seven-session, group-based cognitive behavioural therapy intervention, delivered online by a psychologist and cancer support specialist. Outcome measures will be completed at baseline and 9 weeks, 20 weeks and 32 weeks post baseline. Quantitative data on recruitment, retention, attendance and questionnaire completion rates will be analysed using descriptive statistics. Qualitative data will also be collected to better understand the feasibility and acceptability of the research process and intervention, with data analysed using 'codebook' thematic analysis.
The study has received ethical approval from the Newcastle North Tyneside Research Ethics Committee (ref: 24/NE/0092). The findings will be disseminated to academic and health professionals via a peer-reviewed publication and presentations at relevant conferences. Results will also be disseminated to participants, national cancer organisations and the general public via accessible reports, online presentations and different communication channels.
ClinicalTrials.gov NCT06412341; ISRCTN ISRCTN88199566; IRAS 327507; REC reference 24/NE/0092; funder reference NIHR205415.
乳腺癌是全球女性中最常见的癌症。虽然越来越多的女性在乳腺癌后存活下来，但与治疗相关的身体形象问题很常见且会带来不良后果。尽管如此，这一群体中缺乏经过严格评估且有效的身体形象干预措施。（某研究）已表明面对面实施（干预措施）具有前景。然而，在线实施可能会增加可及性并促进干预措施的可持续性。因此，我们旨在确定开展一项充分有力的随机对照试验以评估（某干预措施）在线实施的可行性。
120名接受过乳腺癌治疗且存在身体形象问题的女性将被等分为（某干预措施组）或标准护理对照组。两种情况下的所有参与者都将收到一本针对癌症患者的身体形象手册。（某干预措施组）参与者还将参加由心理学家和癌症支持专家在线提供的为期7周、每周一次的基于小组的认知行为疗法干预。结局指标将在基线以及基线后9周、20周和32周时完成。将使用描述性统计分析关于招募、留存、（干预措施）参与率和问卷完成率的定量数据。还将收集定性数据以更好地了解研究过程和干预措施的可行性及可接受性，数据将使用“编码本”主题分析法进行分析。
该研究已获得纽卡斯尔北泰恩赛德研究伦理委员会的伦理批准（参考编号：24/NE/0092）。研究结果将通过同行评审出版物以及在相关会议上的报告传播给学术和健康专业人员。结果还将通过易懂的报告、在线展示和不同的沟通渠道传播给参与者、国家癌症组织和公众。
ClinicalTrials.gov NCT06412341；ISRCTN ISRCTN88199566；IRAS 327507；REC参考编号24/NE/0092；资助者参考编号NIHR205415。
